Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression
NCT ID: NCT00622245
Last Updated: 2010-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
166 participants
INTERVENTIONAL
2008-01-31
2009-11-30
Brief Summary
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Detailed Description
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Although there are many treatments for bipolar disorder, few are approved, and they have limitations in their use due to safety and tolerability issues. Recommendations exist to use mood stabilisers, antipsychotics or a combination thereof with or without antidepressants and the polypharmacy employed in many cases is a reason for concern. There is a major medical need for more effective treatments in monotherapy with a reduced potential for adverse effects. This study evaluates the efficacy and safety of the new drug, Lu AA34893, in treatment of depression in patients with bipolar disorder.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lu AA34893: 4 mg
Lu AA34893
per oral doses, divided in twice daily administrations as capsules, during 12 weeks, followed by a one-week tapering period
Lu AA34893: 12 mg
Lu AA34893
per oral doses, divided in twice daily administrations as capsules, during 12 weeks, followed by a one-week tapering period
Lu AA34893: 18 mg
Lu AA34893
per oral doses, divided in twice daily administrations as capsules, during 12 weeks, followed by a one-week tapering period
Quetiapine fumarate
Active reference 300 mg
Quetiapine fumarate
per oral, once daily, during 12 weeks, followed by a one-week tapering period
Placebo
Placebo
per oral doses, twice daily as capsules during 13 weeks
Interventions
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Lu AA34893
per oral doses, divided in twice daily administrations as capsules, during 12 weeks, followed by a one-week tapering period
Quetiapine fumarate
per oral, once daily, during 12 weeks, followed by a one-week tapering period
Placebo
per oral doses, twice daily as capsules during 13 weeks
Eligibility Criteria
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Inclusion Criteria
* Moderate to severe depression
* History of at least one documented mania or hypomania episode
* Absence of current mania or hypomania
Exclusion Criteria
* Any substance disorder with the previous 6 months
* Use of any psychoactive medication (including mood stabilizers) within 2 weeks before randomisation and during the study
* ECT within 6 months before the study
* Female of childbearing potential and not using adequate contraception
18 Years
65 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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H. Lundbeck A/S
Principal Investigators
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Locations
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AU001
Brisbane, , Australia
AU003
Dandenong, , Australia
AU002
Malvern, , Australia
AT002
Vienna, , Austria
AT001
Vienna, , Austria
AT003
Vienna, , Austria
BE004
Brussels, , Belgium
BE003
Charleroi, , Belgium
BE002
Diest, , Belgium
BG004
Stara Zagora, , Bulgaria
CA303
London, , Canada
CA301
Montreal, , Canada
CA302
Orléans, , Canada
FR001
Clermont-Ferrand, , France
FR007
Orvault, , France
FR004
Paris, , France
FR002
Sartrouville, , France
DE004
Berlin, , Germany
DE003
Bochum, , Germany
DE002
Gelsenkirchen, , Germany
LT005
Kaunas, , Lithuania
LT003
Kaunas Region, , Lithuania
LT004
Klaipėda, , Lithuania
LT001
Vilnius, , Lithuania
LT002
Vilnius, , Lithuania
MY004
Klang, , Malaysia
MY005
Kota Kinabalu, , Malaysia
MY002
Kuala Lumpur, , Malaysia
PH002
Las Piñas, , Philippines
PH003
Mandaluyong, , Philippines
PH001
Mandaue City, , Philippines
PL002
Gdansk, , Poland
RO001
Arad, , Romania
RO002
Bucharest, , Romania
RO003
Cluj-Napoca, , Romania
RO005
Craiova, , Romania
SK001
Bratislava, , Slovakia
SK002
Prešov, , Slovakia
KR004
Inchon, , South Korea
KR003
Jeonju, , South Korea
KR005
Kyunggi-do, , South Korea
KR002
Seoul, , South Korea
SE006
Halmstad, , Sweden
SE003
Lund, , Sweden
SE005
Malmo, , Sweden
SE002
Sollentuna, , Sweden
SE001
Stockholm, , Sweden
TW002
Taichung, , Taiwan
UA003
Lviv, , Ukraine
GB001
Oxford, , United Kingdom
Countries
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Other Identifiers
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2007-002551-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12022A
Identifier Type: -
Identifier Source: org_study_id